Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

实施疫苗和治疗评估单位 (VTEU) 临床基地

• 批准号: 10493529
• 负责人: Karen L. Kotloff
• 金额: $ 209.86万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-28 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493529
• 关键词: Academia; Address; Africa; Ambulatory Care Facilities; Area; Award; Biological Products; COVID-19; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Consultations; Contracts; Country; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Disease; Disease Outbreaks; Ebola; Emerging Communicable Diseases; Enrollment; Enteral; Epidemic; Equipment; Evaluation; Formulation; Funding; Goals; Government; Guidelines; Health; Hospitalization; Human; Human Resources; Immune response; Industry; Infection; Influenza; International; Intervention; Investigation; Laboratories; Laws; Leadership; Malaria; Maryland; Medical Device; Mentors; Methods; Modeling; National Institute of Allergy and Infectious Disease; Nongovernmental Organizations; Outpatients; Participant; Patients; Personal Satisfaction; Phase; Policies; Population; Pregnant Women; Prevention; Prevention trial; Preventive; Prognostic Marker; Program Development; Protocols documentation; Public Health; Publishing; Reagent; Regulation; Reporting; Research; Research Personnel; Research Subjects; Resources; Respiratory Tract Infections; Risk; Sampling; Schedule; Scientist; Services; Sexually Transmitted Diseases; Site; Source; System; Systems Biology; Therapeutic; United States National Institutes of Health; Universities; Vaccines; Vulnerable Populations; Work; age group; aging population; base; clinical research site; design; diagnostic tool; dosage; enteric pathogen; epidemiology study; experience; global health; healthy volunteer; human subject; improved; innovation; medical schools; microbiota; neglected tropical diseases; next generation; novel; novel diagnostics; novel vaccines; organizational structure; pathogen; patient population; population based; pre-clinical; predictive marker; prevent; product development; programs; public health emergency; research study; response; sample collection; serosurvey; skills; targeted delivery; therapeutic vaccine; tool; treatment trial; vaccine access; vaccine candidate; vaccine development; vaccine evaluation

Project Summary/Abstract The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health (CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is uniquely poised to accomplish this goal. CVD's expert and accomplished investigative team has complementary skill sets in all areas necessary to address the NIAID priority areas, with established management plans to effectively allocate work and conduct multiple projects simultaneously. CVD is internationally recognized for our capacity and capability to conduct controlled human infection trials for malaria, influenza, and enteric pathogens and to implement treatment and prevention trials in endemic areas for malaria and neglected tropical diseases (NTD), both of which have been a focus of its research for many years. CVD has access to U.S. populations of healthy subjects in all age groups for this research and subjects with special risks, such as patients attending outpatient clinics with sexually transmitted infection (STI) and other conditions that generally do not requiring hospitalization. Strong domestic collaborations at sites experienced in clinical trials provide the CVD's VTEU with surge capacity among healthy subjects of all ages and vulnerable populations such as pregnant women in the U.S. to address public health emergencies. CVD's international collaborators, including two long-standing permanent field sites in Africa, are an invaluable resource for vetted international trial sites in low resource countries endemic for malaria and NTD with experience in conducting high quality NIAID and VTEU studies. This proposal describes mechanisms to implement protocols that arise from concepts proposed by the Leadership Group (LG) and the research community including investigators from other VTEUs, academia, industry, non-governmental organizations, and DMID. These concepts will focus on NIAID priority areas, including malaria, NTD, respiratory infections, particularly influenza, enteric diseases, STI, and emerging infectious diseases and other infectious disease considerations. Under our VTEU contract that is nearing completion (2013-2023), CVD was awarded over 23 Task Orders, enrolled over 1,500 participants, and successfully collaborated with national and international sites. This renewal application is intended to supplement the new VTEU award (1UM1AI148689) that we received in December, 2019 in response to AI18-046; funding for this award was limited to one year as a result of an omission by our Sponsored Programs Administration to include a request for 7 full years of funding. The current proposal seeks to supplement that one year award with an additional 6 years of funding.

项目摘要/摘要 马里兰大学医学院(UMSOM)疫苗开发和全球卫生中心 (CVD)自1974年以来一直是VTEU的既定站点。VTEU的目标是倡导创新的概念 用于临床研究和实施临床现场方案，以评估疫苗、其他预防性生物制品、 用于治疗和预防传染病的治疗学、诊断学和设备，以及心血管疾病 独一无二地准备完成这一目标。CVD的专家和有经验的调查团队 在所有必要领域补充技能，以解决国家开发署优先领域的问题，并建立 管理层计划有效地分配工作并同时进行多个项目。CVD是 国际公认的我们进行受控人类感染试验的能力和能力 疟疾、流感和肠道病原体，并在流行地区实施治疗和预防试验 疟疾和被忽视的热带病(NTD)，这两种疾病都是其许多年来研究的重点 好几年了。对于这项研究和受试者，心血管疾病可以接触到所有年龄段的美国健康受试者群体 有特殊风险的患者，如就诊性传播感染(STI)的门诊患者和 其他一般不需要住院治疗的情况。在网站上进行强大的国内合作 经验丰富的临床试验为CVD的VTEU提供了在所有年龄段的健康受试者中的激增能力 以及美国的孕妇等弱势群体，以应对突发公共卫生事件。心血管疾病 国际合作者，包括在非洲的两个长期的永久外地地点，是一个无价的 在疟疾和非传染性疾病流行的低资源国家审查国际试验点的资源 进行高质量的NIAID和VTEU研究的经验。本提案描述了以下机制： 实施领导小组(LG)和研究提出的概念所产生的协议 社区，包括来自其他VTEU、学术界、工业界、非政府组织的研究人员， 和DMID。这些概念将侧重于NIAID优先领域，包括疟疾、非传染性疾病、呼吸道感染、 特别是流感、肠道疾病、性传播感染和新发传染病等传染病 考虑因素。根据我们即将完成的VTEU合同(2013-2023年)，CVD获得了超过23 任务订单，招募了1500多名参与者，并成功地与国内和国际合作 网站。此续订申请旨在补充我们的新VTEU裁决(1UM1AI148689 2019年12月收到对AI18-046的回应；因此，该奖项的资金限制为一年 我们的赞助项目管理部门遗漏了一项要求提供整整7年资金的申请。这个 目前的提案寻求用另外6年的资金来补充这一一年的奖励。